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An observational clinical study on the changes of intestinal flora between people with circadian rhythm disorders and healthy controls was conducted to explore the relationship between circadian rhythm disorders and human intestinal microorganisms. To reveal the effects of circadian rhythm disorder on human intestinal microorganisms and metabolism on other potential diseases. In this study, 40 people with circadian disorders and 40 healthy controls were recruited. During the study, blood, urine and fecal samples of the subjects were obtained once, and the obtained biological samples were tested and analyzed by serum, urine metabolomics and fecal metagenomics. Subjects were also evaluated on the following scales : Circadian Type Inventory(CTI ). The Epworth Sleeping Scale ( ESS ), Fatigue Scale-14 ( FS-14 ), Maslach Burnout Inventory-General Survey ( MBI-GS ), Athens Insomnia Scale ( AIS ), Insomnia Severity Index ( ISI ), Pittsburgh sleep quality index ( PSQI ), Bristol Stool Scale, Gastrointestinal Symptom Rating Scale ( GSRS ), Connor-Davidson resi.
This study will explore the relationship between circadian rhythm disorders and human intestinal flora. The subjects were included in strict accordance with the inclusion criteria. Feces, blood, urine or other biological samples were collected and analyzed. The clinical data assessment scale and biological samples of the subjects were collected only once.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Circadian rhythm disorders | Observational, no intervention administered. | ||
| Healthy controls | Observational, no intervention administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of gut microbiota | Alpha and Beta diversity of gut microbiota by metagenome. function and sequence-based analysis of gut microbiota microbial genome. The differential flora was obtained through differential analysis, and the correlation analysis was carried out between the differential flora and the differential metabolites. The difference in gut microbiota between people with circadian rhythm disorder and health controls is understood through stool detection. | Only once. The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in metabolites of gut microbiota | The comprehensive and quantitative analysis of the wide arrays of metabolites in biological samples (Fecal). After the difference metabolites are obtained through the difference analysis, the large sample data are analyzed (principal co-coordinates analysis, α/β Diversity, PLS-DA, etc.). We can more fully understand the relationship between intestinal microorganisms and circadian rhythm through metabonomic analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects of the study will recruit employees with certain regularity who are engaged in night or day shifts from Daping Hospital of Army Medical University.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanling Wei, MD | Contact | +8615310354666 | lingzi016@tmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yanling Wei*, MD | Daping Hospital, Army Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Daping Hospital, The Third Military Medical University | Chongqing | Chongqing Municipality | 400042 | China |
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| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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serum, feces, urine
Serum refers to the light yellow transparent liquid separated from plasma by removing fibrinogen after blood coagulation.
Faecalis, refers to the excretion of human and animal.
Urine, is a fluid like metabolite excreted from the human body.
| Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00) |
| Changes of serum metabolites | The comprehensive and quantitative analysis of the wide arrays of metabolites in biological samples (Serum). After the difference metabolites are obtained through the difference analysis, the large sample data are analyzed (principal co-coordinates analysis, α/β Diversity, PLS-DA, etc.). Through metabolites analysis, we can more comprehensively understand the relationship between intestinal microorganisms and circadian rhythm and blood metabolites. | Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00) |
| Changes of urine metabolites | The comprehensive and quantitative analysis of the wide arrays of metabolites in biological samples (Urine). After the difference metabolites are obtained through the difference analysis, the large sample data are analyzed (principal co-coordinates analysis, α/β Diversity, PLS-DA, etc.). Through metabolites analysis, we can more comprehensively understand the relationship between intestinal microorganisms and circadian rhythm and urine metabolites. | Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00) |
| Circadian Type Inventory | The amplitude and stability of their rhythms using questionnaires. (Circadian Type Inventory) CTI includes two subscales, of which the Flexibility/Rigidity scale has five items. The higher the score, the stronger the flexibility of rhythm. Languid/Vigorous has six items, and the higher the score, the more serious the fatigue of the human body. | Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00) |
| Gastrointestinal Symptom Rating Scale (GSRS) | The GSRS is a brief, fairly comprehensive assessment of common gastrointestinal symptoms. The total score is 112. The higher the score, the more serious the gastrointestinal symptoms. | Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00) |
| The Epworth Sleeping Scale(ESS) | The Epworth sleepiness scale (ESS) is a widely used tool which has been validated as a measure of sleepiness. The total score is 24 points. The higher the score, the more serious the sleepiness. | Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00) |
| Fatigue Scale-14(FS-14) | Evaluate the severity of people's fatigue. The total score is 14 points. The higher the score, the more fatigue. | Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00) |
| Maslach Burnout Inventory-General Survey(MBI-GS) | The AIS is a self-assessment psychometric instrument designed for quantifying sleep difficulty based on the ICD-10 criteria. The total score is 21 points. The higher the score, the more serious the insomnia. | Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00) |
| Athens Insomnia Scale(AIS) | The Maslach Burnout Inventory-General Survey (MBI-GS) is a widely used scale that measures burnout in the general professions. Use the standard 100 point scale for calculation. After scoring more than 50 points, the higher the score, the less positive the attitude towards work. | Only once. The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00) |
| The Depression Anxiety Stress Scale (DASS) | The DASS-21 can validly be used to measure the dimensions of depression, anxiety, and stress. The total score is 63 points. The higher the score, the worse the mental state. | Only once. The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00) |